A clinical study involves research using patient volunteers (also called participants) that is intended to add medical knowledge and expand treatment options for patients. There are two main types of clinical studies: clinical trials and observational studies. The Thurston Arthritis Clinical Trials program is involved in both types of clinical studies.

All clinical trials follow a study plan, or protocol, that ensures the health and safety of the participants. It explains what the study will do, how it will be carried out, and who may participate. All study protocols are rigorously evaluated by our faculty physicians and the UNC Office of Human Research Ethics.

For more information about clinic trials at Thurston, contact:For Arthritis, contact Diane Bresch at 919-966-0545.

Before participating in a clinical trial you should ask the following questions:

Who is doing the study?

What is the study about?

Will the study help to understand my condition?

What do I have to do in the study?

Are there any side effects to any medications?

How much of my time is going to be involved?

How often do I have to go to the clinical trial site?

How long will each visit be?

Why should you volunteer?

People volunteer to participate in clinical trials for many reasons.

They wish to benefit others and science research.

They anticipate a personal benefit, a better treatment or outcome for their condition.

The health of participants is protected through the study protocol. Clinical trials are also approved by an Institutional Review Board (IRB) before enrolling participants in the study. An IRB performs critical oversight functions for research conducted on people to ensure that the trials are safe for the participants and scientifically sound. The IRB Monitors and reviews the study through the entire duration of the study.

Once I start a trial, I can’t quit.

Participants can drop out of a clinical trial at any time for any reason. If you do not like the trial, are not feeling well or the trial is not going like you think it should, you have the option to drop out.

The blood samples that are collected during a clinical trial can be used for anything.

Blood samples are usually drawn for laboratory tests to assess the progress of the study. They are not used for any purpose that is not explicitly stated in the study consent forms. Sometimes a patient may be asked to donate additional blood samples to help develop new laboratory tests for diagnosing and treating diseases. These research samples require a separate consent form, and are optional.

If my doctor asks me to participate in a trial, I can’t turn it down.

Participating in a clinical trial is on a voluntary basis; your doctor will still be your doctor and treat you regardless of whether you participate of not.

If I participate in a clinical trial, insurance company might deny my coverage.

Your insurance company cannot deny you any coverage if you participate in a clinical trial. Insurance companies are not informed of your participation.